Medical marijuana (also called medical cannabis) is whole plant marijuana or chemicals in the plant used for medical purposes.

Cannabinoids are substances in medical cannabis that act on cells in the body, including the brain. The two main cannabinoids used in medicine are tetrahydrocannabinol (THC) and cannabidiol (CBD).

The FDA recently approved the use of Epidiolex (a plant-based formulation of CBD) to treat seizures for people 2 years of age and older with Dravet syndrome and Lennox-Gastaut syndrome (LGS).

Medical cannabis, CBD, and THC all have possible side effects. The most common side effects of CBD included sleepiness, diarrhea, fatigue, and decreased appetite. CBD also interacts with some other seizure medicines.

The children presented typical signs of intoxication by Δ9-THC (inappropriate laughter, ataxia, reduced attention, and eye redness) after using a CBD-enriched extract. The extract was replaced by the same dose of purified CBD with no Δ9-THC in both cases, which led to improvement in intoxication signs and seizure remission.

These results from an uncontrolled study support the animal studies and prior reports showing that CBD may be a promising treatment for TRE and it is generally well-tolerated in doses up to 25mg/kg/day. Epidiolex is now being investigated in randomized controlled studies in DS and LGS.

“It is important to know that legalizing marijuana would not mean greater access to potentially effective treatment for children and adults with a medical illness such as epilepsy. Cannabidiol, or CBD, is not at all marijuana.”

CBD is not medical marijuana. CBD does not get anyone high nor does it increase appetite. It may be beneficial in treating children with rare forms of epilepsy, often difficult to control with medication or other available treatments, but it does not work for everyone with seizures.

“The stories of kids having fewer seizures described in the media are heartwarming and can possibly be of some benefit – just like many other medications available to treat seizures,” Dr. Patel adds.

What are the possible side effects?
CBD can cause nausea, diarrhea, or worse, affect the liver.

Dr. Patel states, “There is nothing natural about marijuana and its components. It is broken down in a person’s liver, similar to many other medications. It has interactions with other medications and is still not fully understood. If further studies show that CBD is safe and effective, it will be sent to the FDA for official approval. If the FDA approves this medication, it will be available in the form of a prescription and no laws will need to be changed.”

“Legalization would make our jobs as medical providers more difficult as we will not know what changing, non-tested preparations a child may be getting. I understand that parents are desperate and want to help their children, however, it is dangerous to give a child or patient a product unless it has been studied properly and is the same consistent product each time.” If the ongoing trials show that Epidiolex is safe and effective, then all people can have access to it through a prescription and know that it has been properly tested and is consistent each month. Medical providers will know how to dose it and it will be regulated by the FDA.

Background Paper on Legalization of Marijuana for Medical Use Prepared for the Members of the Georgia Medical Cannabis Commission by National Families in Action1.Reviewing the conditions, needs, issues, and problems of medical cannabis
1a. No Randomized Controlled Clinical Trials
1b. Most Medical Marijuana States Do Not Test for Potency or Contaminants
1c. FDA Cracking Down on CBD Producers Making Unsubstantiated Medical Claims
1d. Five percent THC Makes People High
1e. Marijuana Edibles Are Hurting Children
1f. Pharmaceutical CBD Products in FDA Clinical Trials vs Artisanal CBD
1g. What is a medical marijuana doctor?
1h. Is marijuana about medicine or money?

2.Evaluating the Best Practices, Experiences, and Results of Medical Cannabis in Other States
2a. Advocacy vs Reality
2b. A Commercial Medical Marijuana Industry Increases Marijuana Use
2c. Availability Drives Use among Children
2d. Doctors, Scientists Dismayed at States’ Legalizing Marijuana for Medical Use
2e. Questions Commission Members Might Want to Consider3.Recommending Any Proposed Action or Legislation You Deem NecessaryDetermining Which State Department or Departments Should Have Oversight of Such a System
3a. Recommendations 4. Addendum 5. References

Safety concerns coupled with a lack of evidence of efficacy in controlled studies result in a risk/benefit ratio that does not support use of marijuana for treatment of seizures at this time. Healthcare professionals, patients, and caregivers are reminded that use of marijuana for epilepsy may not be advisable due to this lack of information on safety and efficacy.

"We've seen children that have had rather severe reactions while on medical marijuana products," said Amy Brooks-Kayal, M.D., a Colorado pediatrician who is president of the American Epilepsy Society. "We don't know if that's from the medical marijuana product or something else, because it wasn't done in a controlled setting."
Dr. Brooks-Kayal supports the clinical trials underway now across the country, and advises parents not to treat their sick children with cannabis oil until clinicial trials are complete.
"Just because a single child or person or even a few may respond well to a treatment, that doesn't mean that the majority of them will," she said.

Among the 137 people who completed the study, the number of seizures fell by an average of 54 percent, according to a team led by Dr. Orrin Devinsky, of New York University Langone Comprehensive Epilepsy Center in New York City.
Keep in mind that Epidiolex is VERY different than the so-called low THC strains of marijuana (also known as Charlotte’s Web) that are being grown and sold in several states. Unlike Epidiolex, the strains of marijuana are not cloned and the end products vary widely. Most importantly, these strains contain varying levels of THC whereas Epidiolex is virtually pure CBD.

A study by a team from Children's Hospital Colorado that was presented during the AES Annual Meeting in December 2014 and has recently been accepted for publication in the journal Epilepsy & Behavior, found that artisanal "high CBD" oils resulted in no significant reduction in seizures in the majority of patients and in those for whom the parents reported improvements, these improvements were not associated with improvement in electroencephalograms (EEGs), the gold standard monitoring test for people with epilepsy.

Additionally, in 20% of cases reviewed seizures worsened with use of cannabis and in some patients there were significant adverse events. These are not the stories that you have likely

heard in your public hearings, but they are the reality of practitioners at Children's Hospital Colorado who have cared for the largest number of cases of children with epilepsy treated with cannabis in the U.S.

My fear is that, if CBD is made widely available in an uncontrolled way, families will run to it because of the hype, often using it to replace rather than augment current therapy. Some children might benefit. But it will not work for everyone and, if it is used as a stand alone therapy in children for whom it does not work, then some of those children will die. These children need to be protected from uncontrolled seizures but they also need to be protected

from unproven therapies. Sadly, the good intentions of their desperate, loving parents have the potential to put some of these children in harm’s way.

But these results should be taken with a grain of salt, Hussain said. "This is generally a pretty desperate group of patients and parents, and I think they are highly invested in the belief and the hope that these cannabis extracts are truly effective," he said.

Considering Marijuana

In 2011 (more than 2.5 years ago) in "Marijuana: A Viable Epilepsy Therapy?" I reviewed the possibility of marijuana (Cannabis sativa) for the treatment of epilepsy. That article concluded, "More research is needed before patients should consider marijuana for seizure relief, particularly because this represents criminal activity under US federal law and may be accompanied by adverse medical (and legal) events."

What Hasn't Changed Since 2011?

What hasn't changed is the desperation of people with uncontrolled seizures and their families. Heather Jackson, the mother of Zaki, one of the children who responded to Charlotte's web, stated in a Huffington Post video interview, "If you wanted to take my money, I would give it to you. I wanted to save my boy."[13] Such vulnerable families need to be protected from scams, false promises, and dangerous drugs.

Conclusions

Despite the recent journalistic hype, my 2011 conclusions about "medical marijuana" have not changed. Marijuana is still a schedule I drug. It is not FDA-approved for the treatment of epilepsy or any other neurologic condition. Its medical (and recreational) use is still illegal under federal law. There are no controlled trials demonstrating that marijuana is "safe" or "effective" for the treatment of epilepsy. On the other hand, there is evidence that marijuana may be harmful, particularly in the developing brain after regular use. Synthetic cannabinoids appear even more toxic.

However, for many people with epilepsy, seizures cannot be controlled with FDA-approved medications. Other treatment options, such as the vagus nerve stimulator, responsive neurostimulation, or the ketogenic diet, may not work or may not be appropriate choices. For patients who have exhausted conventional therapies, medical marijuana, for which there is anecdotal evidence of seizure control, could be considered as an unproven, "compassionate use" alternative. Any such use of marijuana should be carefully monitored by a physician. A better alternative for children with intractable epilepsy would be enrollment in the new Epidiolex clinical trial.

In a survey and other anecdotal reports, parents of children with drug-refractory epilepsy syndromes have reported successful treatment with cannabidiol-enriched marijuana. But little high-quality evidence is available about the efficacy and safety of cannabidiol in patients with Dravet, Lennox-Gastaux, and other pediatric epilepsy syndromes, as shown by a recent Cochrane Collaboration review of four randomized trials totaling 48 patients with epilepsy that found no adverse effects with 200-300 mg daily over short periods but did not report on the efficacy of the drug.